Tuesday, July 17, 2007

Apparently, supporters of the proposed FDA tobacco legislation have come to realize that putting cigarette regulation into the hands of the FDA would create a perceived seal of approval that would falsely make the public believe that cigarettes have been made safer, potentially increasing cigarette consumption. In fact, they apparently believe it is so much of a problem that they have inserted language into the bill that would prevent cigarette companies from merely telling the public that the FDA regulates cigarettes.

In a last hour maneuver, the Senate Health, Education, Labor, and Pensions Committee Chairman - Senator Edward Kennedy - inserted a provision into the bill which would prevent the companies from making any statement to the public, in any communication, that informs people of the fact (the truth) that cigarettes are now regulated by the FDA.

The provision states that cigarette companies may not make "any statement directed to consumers through the media or through label, labeling, or advertising that would reasonably be expected to result in consumers believing that the product is regulated, inspected, or approved by the Food and Drug Administration, or that the product complies with the requirements of the Food and Drug Administration...".

The reason for this provision, as stated in the legislation?

"If manufacturers are permitted to state or imply in communications directed to consumers that a tobacco product is approved or inspected by the Food and Drug Administration or complies with Food and Drug Administration standards, consumers are likely to be confused and misled. Such a statement could result in consumers being misled into believing that the product is endorsed by the Food and Drug Administration for use or in consumers being misled about the harmfulness of the product because of such regulation, inspection, approval, or compliance."

The Rest of the Story

You know that regulation of cigarettes by the FDA is a terrible idea if the supporters of the bill have to insert a clause into it preventing tobacco companies from telling the public that the FDA regulates cigarettes. You know that FDA regulation of cigarettes is a pretty bad idea if we need to hide the truth from the public lest it have the expected adverse consequences for the public's health.

Apparently, the only way this legislation will work is if we trick people into thinking that the FDA does not regulate cigarettes.

Think about it. What kind of cockamamie regulatory scheme depends upon the public not knowing about that scheme in order to avoid severe public health consequences?

How sensible can a regulatory approach be if we need to hide from the public the very fact that the regulatory scheme is in place?

Clearly, precluding the tobacco companies from telling the public that the FDA regulates cigarettes is not going to keep this information from the public. The legislation is getting tremendous publicity, and I would bet that even if it is not enacted, a substantial proportion of the public is going to think that the FDA regulates cigarettes just because they heard so much about it. Surely, people are going to catch wind of the fact that cigarettes are under FDA's regulatory jurisdiction. Whether the tobacco companies tell them or not.

So the perceived FDA seal of approval that the bill's supporters are finally worried about is going to happen, despite the newly inserted provision that prevents the tobacco companies from telling the public the simple truth.

Ironically, in an apparent effort to save face in the light of this late realization that the regulatory scheme is indeed going to create the FDA seal of approval that I warned about months ago (actually, years ago), bill proponents hastily inserted a provision that is such an act of haste and desperation that it is unconstitutional.

I believe that this provision violates the tobacco companies' rights under the First Amendment to the Constitution. I think it clearly violates their free speech rights.

What the bill does, if it passes, is prevent tobacco companies from making a simple statement of the clear, undeniable, universally recognized truth: that cigarettes are regulated by the FDA. There is no compelling justification for interfering with the companies' First Amendment rights in this situation. I doubt that this provision would ever hold up if the companies rightfully challenge it.

How can you tell companies that they cannot make a simple statement of the truth that is widely known and widely disseminated through other sources?

Clearly, the FDA can regulate the labeling of cigarettes. And the FDA can certainly prevent companies from making statements that are false or misleading. But there is no compelling government interest that would justify taking away free speech rights to tell the public the truth.

Here is the rub: there would be no deception in the companies stating that the FDA regulates cigarettes. This would be undeniably true if the legislation is enacted; there would not be a shred of deception.

That is how foolish this legislation is. So foolish that we need to infringe upon the companies' First Amendment rights in order to make sure that the public doesn't catch wind that the legislation is in place.

The truth is that for this legislation to be effective and not harm the public's health by creating the perception of an FDA stamp of approval, the bill would have to do far more than prevent cigarette companies from telling the public that the FDA regulates cigarettes. It would have to require that public statements be made to the effect that the legislation did not pass. It would have to require a media conspiracy to lie to the public about the legislation's fate. Otherwise, it is going to be quite obvious to the public that cigarette safety is under the jurisdiction of the Food and Drug Administration.

Apparently, the bill's sponsors are so clear on the fact that the legislation will unlikely have any health benefits in terms of producing a safer cigarette that they are uncomfortable with the idea that the public might even be informed that a manufacturer's cigarettes comply with the requirements of the FDA.

If the FDA legislation were, as suggested by its anti-smoking group supporters, going to produce safer cigarettes, then we would not need to go to extreme measures (violating freedom of speech rights) in order to shield the public from finding out that indeed, cigarettes on the market do comply with FDA requirements.

In a brilliant way that I only wish I could have thought of, Senator Kennedy has revealed to the nation just how stupid this legislation is. What the bill is now essentially saying is the following: "We previously issued propaganda suggesting that FDA regulation of cigarettes will save millions of lives by reducing cigarette smoking and making the product safer through product standards. However, we now acknowledge our opponents' arguments that in reality, the legislation will create a perceived stamp of approval for cigarettes, undermining public health messages about the hazards of smoking. In addition, we now acknowledge that the product probably won't be safer, and that we need to go to great lengths to make sure that the public does not think that cigarettes actually comply with the FDA standards. Given our propaganda, they may think that compliance with FDA safety standards implies a safer product. But the truth is that our proposed safety standards are not actually 'safety' standards."

The rest of the story is that hastily, and obviously without too much insight, proponents of the FDA legislation have written into the bill the exact reasons to kill it. The bill now exposes its own folly. It reveals its lack of sensibility.

How ironic that what should be the death knell for this legislation was a last-minute, desperate act by the bill's chief sponsor.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.